Why are we dragging our feet when more automation in health care will save lives?

April 21, 2017 by Thomas Hooven, The Conversation
From closed-loop ventilators to smarter vital sign monitors, automation has untapped potential to improve medical outcomes. Credit: www.shutterstock.com

As a neonatologist, I worry about patients with pulmonary hypertension. This unforgiving disease, sometimes seen after premature birth, can end with sudden death from constricting blood vessels in the lungs. One minute a baby in the neonatal ICU may be sleeping comfortably; moments later, doctors and nurses are giving chest compressions and rescue medications.

A pulmonary hypertension crisis, as these frightening episodes are called, starts with a drop in the . That drop triggers a monitor to beep. It's up to the nurse to hear the sound, come to the bedside and take action.

The first and most effective step in stopping a pulmonary hypertension crisis is simple: Give oxygen. But a nurse caring for another patient might be delayed for 30 seconds, and the loss of that time can lead to brain injury or death.

In an age of self-driving cars and 400-ton airplanes that can land themselves in blinding fog, it makes no sense that hospitalized patients are surrounded by lifesaving machinery that can be activated only by a person pressing a button or turning a knob.

Modern transportation augments human judgment and reaction times with a computer's superior ability to continuously respond to dozens of fluctuating variables. Yet in medicine, safety remains stubbornly reliant on human intervention.

FDA regulation impedes innovation

My patients with are often attached to a respirator with adjustable oxygen settings. The respirator sits inches below the monitor that indicates how much oxygen is in the blood. But the two machines can't communicate with each other. If they could, it would be possible to increase the flow of oxygen automatically the moment a crisis is detected.

In 2009, engineers developed just this kind of closed-loop respirator and introduced it in several hospitals as part of a feasibility study. It increased the time premature babies spent at a safe oxygen level by more than two hours per day. But no biotechnology company has marketed the idea.

There are other examples of automated systems with unrealized potential to save lives, and not just in the neonatal ICU. Software that scans an ECG for subtle heartbeat variability can identify patterns – undetectable to the human eye – that indicate an elevated risk of heart attack. Hospital beds that play audible feedback during an emergency promote more effective CPR. Yet patients are not benefiting because neither of these tools has been commercialized.

Why haven't these innovations attracted the industry backing necessary to make them widely available?

One reason is that the process of getting FDA approval for new devices – particularly those deemed "life-sustaining" – is often even more complicated and expensive than getting approval for drugs. In the Journal of Public Economics, Harvard Business School professor Ariel Dora Stern recently described how FDA hurdles discourage companies from investing in innovation.

Often, the more profitable strategy is to wait for someone else to spend the time and money required to get approval for a new device, and then enter the market later with something similar that will face less scrutiny. Dr. Stern estimates that regulatory obstacles add an average of US$6.7 million to the cost of introducing a new medical device. For a company developing an ICU monitor, for instance, that will ultimately sell for less than $35,000 per unit, this up-front commitment can be prohibitive.

A consequence is that small biotechnology firms (with annual revenue less than $500 million) rarely gamble on getting new inventions approved. Dr. Stern's paper notes that less than 17 percent of novel device applications to the FDA come from small companies. This is different from new drug applications, the majority of which originate at smaller firms.

What's behind this discrepancy? Research has shown that while companies pay a steep price for pioneering new medical devices, the first firm to market a new type of drug often gets favorable treatment from the FDA. This raises the incentive for pharmaceutical startups to pursue innovation. In contrast, when it comes to medical devices, the current system discourages all but the biggest players from entering the arena.

And even when a new device has been approved, there is no strong impetus for hospitals and clinics to buy in. Even if they can afford upgrades, medical sites are free to use older equipment, with fewer safety mechanisms, long after improved versions become available.

A chance for Washington to improve health care

In contrast, a variety of government initiatives prod transportation companies to modernize. For example, the Federal Aviation Administration offers rebates to aircraft owners to offset the cost of advanced navigation technology that prevents midair collisions. The Federal Rail Administration is overseeing mandatory, nationwide installation of a GPS-based system to slow down speeding trains automatically.

There is an opportunity here – beyond the messy Obamacare debate – for the White House and congressional Republicans to stimulate economic growth in the biomedical sector while improving patient safety. Streamlining the approval process for new devices and offering financial incentives for early adopters would not threaten anti-regulatory groups, and would allow the new administration to claim progress in .

President Trump has expressed interest in expediting pharmaceutical approvals, something FDA commissioner nominee Scott Gottlieb also supports. But most drugs help only a small segment of the population.

The president and Dr. Gottlieb should commit to advancing commonsense technology that makes health care better for all.

I'm not suggesting that machines should take over for health professionals. As in the manufacturing industry, the medical field is experiencing mounting anxiety about job displacement. There are many perceived threats, from artificial intelligence X-ray interpretation to robot nurses.

Those things might become commonplace, but they will never supplant the human relationships and insights at the core of medical practice. Neither will the kinds of safety innovations I'm recommending. With help from our leaders, physicians can take better care of patients by bringing more automation into our wards and offices.

Explore further: Medical device regulation in the EU and US needs urgent reform, say experts

Related Stories

Medical device regulation in the EU and US needs urgent reform, say experts

June 28, 2016
Medical devices approved first in the European Union (EU) are associated with a greater rate of safety issues, finds a study published by The BMJ today.

Light can be used to examine the lungs of premature babies

March 22, 2016
Premature babies have a hard time getting the oxygen they need as their lungs are not sufficiently developed. Today you can only use X-rays to see how much air babies' lungs contain, but, according to research from Lund University ...

FDA approved almost all medical devices in the last year

December 2, 2015
The Food and Drug Administration says it approved 98 percent of all high-risk medical devices submitted during the most recent fiscal year, the highest rate in at least 15 years.

Researchers develop new method for looking into the lungs

December 18, 2015
For the first time, researchers have succeeded in producing 3D images showing oxygen and CO2 transport in the lungs. The new method provides hope for better treatment of COPD and lung cancer.

Recommended for you

Cholesterol-lowering drugs may fight infectious disease

August 21, 2017
That statin you've been taking to lower your risk of heart attack or stroke may one day pull double duty, providing protection against a whole host of infectious diseases, including typhoid fever, chlamydia, and malaria.

Data revealed under FOI shows benefits of multiple sclerosis drug currently blocked by regulators

August 17, 2017
A drug that is blocked by the EU regulatory system has now been found to improve the quality of life of people with multiple sclerosis (MS), according to a study by Queen Mary University of London (QMUL).

Opioids overused in migraine treatment, regardless of race, study finds

August 17, 2017
African-Americans are more likely to experience debilitating migraine headaches than whites, but a new study probing the issue found no evidence of racial disparities in treatment practices.

Finding better ways to reduce serious drug side effects

August 14, 2017
Many of the medicines we depend on to treat disease—and even to save our lives—pose potentially serious risks along with their benefits. Data from the U.S. Centers for Disease Control and Prevention indicate that about ...

Ultrasound-triggered liposomes for on-demand, local anesthesia

August 10, 2017
Researchers at Boston Children's Hospital have found a new way to non-invasively relieve pain at local sites in the body; such systems could one day improve pain management by replacing addictive opioids and short-lasting ...

Independent pharmacies and online coupons help patients save money on drugs

August 8, 2017
Uninsured patients or those with limited prescription drug coverage can save significant money by buying their drugs at independent pharmacies instead of big box, grocery or chain drug stores and by using discount coupons, ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.